PARCHE LEON MILAGROSO DUAL ACTION- capsaicin, menthol patch

Parche Leon Milagroso by

Drug Labeling and Warnings

Parche Leon Milagroso by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.0375%

Menthol 5%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backaches
• arthritis
• strains
• sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Allergy Alert: This product contains natural rubber latex which may cause allergy reactions.

Do not use

• on wounds or damaged skin
• with a bandage or heating pad
• on sensitive skin
• if allergic to any ingredients in this product

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults & children 12 yrs of age & older: apply to affected area not more than 3 to 4 times daily
• children under 2 year of age: consult a doctor
• clean and dry affected area
• remove patch from film
• apply sticky side of patch to affected area
• use one patch at a time
• leave patch on affected area for up to 8-hours at a time

Inactive ingredients:

aloe barbadensis leaf (aloe vera gel) juice, diazolidinyl urea, EDTA disodium, glycerin, iodopropynyl butylcarbamate, methylparaben, polysorbate 80, propylparaben, sodium polyacrylate, water.

Other information:

• store at room temperature 59-86°F (15-30°C)
• do not store in direct sunlight or expose to excessive heat

TAMPER EVIDENT:

Do not use if packet containing the patch is torn or broken.

Questions & comments?

1-899-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadelusa.com

PRINCIPAL DISPLAY PANEL

Topical Analgesic Patches

Dual Action Pain Relief

For the temporary relief of:

• Sore Muscules
• Backache
• Arthritis
• Joint Pain

INGREDIENTS AND APPEARANCE

PARCHE LEON MILAGROSO  DUAL ACTION
capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
METHYLPARABEN (UNII: A2I8C7HI9T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-046-06	6 in 1 CARTON	02/01/2016
1		2.27 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2016

Labeler - Pharmadel LLC (026095439)